Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03161795
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2017-05-16
Brief Title:
Addressing the Risks of Long-Term Opioid Therapy in Chronic Noncancer Pain
Sponsor:
Seoul National University
Organization:
Seoul National University
Study Overview
Official Title:
Addressing the Risks of Long-Term Opioid Therapy in Chronic Noncancer Pain A National Multicenter and Observational Cross-sectional Study in South Korea
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PURPOSE Assess the risks of long-term opioid therapy especially opioid use disorders such as opioid-related chemical coping in chronic noncancer pain patients
Pain particularly chronic pain is a major threat to the quality of life worldwide and will become more so as the average age increases Currently over 30 of the worlds population is known to have chronic pain Among a plethora of treatment options opioid agonists is one of treatment options for moderate to severe chronic pain Although its consumption has increased during the last two decades3 it remains below the requirements in most regions including the Asian countries In South Korea S Korea opioid consumption for medical purposes in 2015 was still below average ranked 43rd globally and 30th among 35 Organisation for Economic Co-operation and Development OECD countries 55 mgcapita in S Korea vs 258 mgcapita in an average of OECD countries Conversely in countries with high opioid consumption such as the United States of America US drug overdose deaths the majority involving an opioid have nearly quadrupled since 1999
The up to date literature on opioid use disorder OUD is characterized by great variability of definitions measurements demographics and opioid use duration Moreover an overwhelming majority of the studies took place in the US the country with the highest opioid consumption and a current opioid crisis Additionally stringent restrictions and regulations to prevent OUD may result in inadequate pain control and insufficient opioid therapy especially in countries with relatively low-moderate opioid consumption rates Therefore in compliance with growth in medical opioid use and the lack of studies in countries with low-moderate opioid consumption it is necessary to determine the occurrence of OUD in chronic noncancer pain CNCP patients receiving long-term opioid therapy LtOT
In this study we will perform a national multicenter observational cross-sectional study to address the current status of opioid treatment for CNCP in S Korea a country with moderate opioid consumption The ultimate aims of this study are to estimate the frequency of OUD such as OrCC to evaluate the functional and psychiatric characteristics of patients and to determine the risk factors associated with OUD in CNCP patients receiving LtOT
Pain particularly chronic pain is a major threat to the quality of life worldwide and will become more so as the average age increases Currently over 30 of the worlds population is known to have chronic pain Among a plethora of treatment options opioid agonists is one of treatment options for moderate to severe chronic pain Although its consumption has increased during the last two decades3 it remains below the requirements in most regions including the Asian countries In South Korea S Korea opioid consumption for medical purposes in 2015 was still below average ranked 43rd globally and 30th among 35 Organisation for Economic Co-operation and Development OECD countries 55 mgcapita in S Korea vs 258 mgcapita in an average of OECD countries Conversely in countries with high opioid consumption such as the United States of America US drug overdose deaths the majority involving an opioid have nearly quadrupled since 1999
The up to date literature on opioid use disorder OUD is characterized by great variability of definitions measurements demographics and opioid use duration Moreover an overwhelming majority of the studies took place in the US the country with the highest opioid consumption and a current opioid crisis Additionally stringent restrictions and regulations to prevent OUD may result in inadequate pain control and insufficient opioid therapy especially in countries with relatively low-moderate opioid consumption rates Therefore in compliance with growth in medical opioid use and the lack of studies in countries with low-moderate opioid consumption it is necessary to determine the occurrence of OUD in chronic noncancer pain CNCP patients receiving long-term opioid therapy LtOT
In this study we will perform a national multicenter observational cross-sectional study to address the current status of opioid treatment for CNCP in S Korea a country with moderate opioid consumption The ultimate aims of this study are to estimate the frequency of OUD such as OrCC to evaluate the functional and psychiatric characteristics of patients and to determine the risk factors associated with OUD in CNCP patients receiving LtOT
Detailed Description:
Chronic pain is a devastating disease often treated inadequately More than 30 percent of the world population suffers from chronic pain Among a plethora of treatment options opioid agonists is one of treatment options for moderate to severe chronic pain Although its consumption has increased during the last two decades it remains below the requirements in most regions including the Asian countries In South Korea S Korea opioid consumption for medical purposes in 2015 was still below average ranked 43rd globally and 30th among 35 Organisation for Economic Co-operation and Development OECD countries 55 mgcapita in S Korea vs 258 mgcapita in an average of OECD countries However it is remarkable that the opioid consumption in S Korea has increased 5-6 times since 2005 10 mgcapita ranking 3rd among Asian countries preceded only by Vietnam 62 mgcapita and Malaysia 60 mgcapita
One of the reluctant factors to prescribe opioids is induced reward responses resulting in opioid use disorders OUD Particularly in chronic noncancer pain CNCP concerns regarding drug dependence in the long-term opioid therapy LtOT remain its use controversial The spectrum of OUD in CNCP patients is wide and varies from misuse without a compliant intake to addiction with a severe aberrant consumption Between the extremes opioid-related chemical coping OrCC may lie in a middle ground group characterized by an inappropriate use of opioids to cope with emotional distress Although OrCC is a terminology first used in cancer patients a recent study found a high correlation between the reports of aberrant medication-taking behavior by experienced providers and chemical coping by CNCP patients
OrCC should be distinguished from psychologic addiction a neurobiological disease that corresponds with the most severe substance-use disorder referring to neuroplasticity and a substantial loss of self-control All addicts are eventually chemical copers but not all chemical copers are addicts A better understanding of this intermediate status may be crucial to prompt to identify the risk of severe OUD and re-direct their management to avoid unnecessary opioid toxicity and achieve adequate pain control However studies to measure OrCC are scarce and the evidence of OUD in CNCP in countries with relatively low opioid consumption is practically unavailable
The up to date literature on OUD is characterized by great variability of definitions measurements demographics and opioid use duration Moreover an overwhelming majority of the studies took place in the United Stated of America US the country with the highest opioid consumption and a current opioid crisis Despite their over-consumption however studies in those countries showed that CNCP is still undertreated and even suggested that OUD might not be related to the prescription to pain patients From a different angle stringent restrictions and regulations to prevent OUD may result in inadequate pain control and insufficient opioid therapy especially in countries with relatively low- moderate opioid consumption rates Therefore to strike a balance when treating pain with opioids it is indispensable to determine the characteristics of OUD in CNCP patients with LtOT in countries with low-moderate opioid consumption Moreover in S Korea there are not available statistics regarding the OUD occurrence in CNCP patients and national guidelines on LtOT in CNCP have not been developed
In this study we will perform a national multicenter observational cross-sectional study to address the current status of opioid treatment and OUD for CNCP in S Korea a country with moderate opioid consumption since 2010 The availability of up-to-date data on OUD is necessary for the development of national guidelines to prevent severe harms of opioids enhance patients and physicians satisfaction potentiate opioids benefits and guaranty adequate pain control in the CNCP population The ultimate aims of this study are to estimate the frequency of OUD such as OrCC to evaluate the patients functional and psychiatric characteristics and to determine the risk factors associated with OUD in CNCP patients receiving LtOT The results of this study will help to seize the occurrence of OUD in countries with low-moderate opioid consumption thus it will approach the real risk effect of LtOT in CNCP
One of the reluctant factors to prescribe opioids is induced reward responses resulting in opioid use disorders OUD Particularly in chronic noncancer pain CNCP concerns regarding drug dependence in the long-term opioid therapy LtOT remain its use controversial The spectrum of OUD in CNCP patients is wide and varies from misuse without a compliant intake to addiction with a severe aberrant consumption Between the extremes opioid-related chemical coping OrCC may lie in a middle ground group characterized by an inappropriate use of opioids to cope with emotional distress Although OrCC is a terminology first used in cancer patients a recent study found a high correlation between the reports of aberrant medication-taking behavior by experienced providers and chemical coping by CNCP patients
OrCC should be distinguished from psychologic addiction a neurobiological disease that corresponds with the most severe substance-use disorder referring to neuroplasticity and a substantial loss of self-control All addicts are eventually chemical copers but not all chemical copers are addicts A better understanding of this intermediate status may be crucial to prompt to identify the risk of severe OUD and re-direct their management to avoid unnecessary opioid toxicity and achieve adequate pain control However studies to measure OrCC are scarce and the evidence of OUD in CNCP in countries with relatively low opioid consumption is practically unavailable
The up to date literature on OUD is characterized by great variability of definitions measurements demographics and opioid use duration Moreover an overwhelming majority of the studies took place in the United Stated of America US the country with the highest opioid consumption and a current opioid crisis Despite their over-consumption however studies in those countries showed that CNCP is still undertreated and even suggested that OUD might not be related to the prescription to pain patients From a different angle stringent restrictions and regulations to prevent OUD may result in inadequate pain control and insufficient opioid therapy especially in countries with relatively low- moderate opioid consumption rates Therefore to strike a balance when treating pain with opioids it is indispensable to determine the characteristics of OUD in CNCP patients with LtOT in countries with low-moderate opioid consumption Moreover in S Korea there are not available statistics regarding the OUD occurrence in CNCP patients and national guidelines on LtOT in CNCP have not been developed
In this study we will perform a national multicenter observational cross-sectional study to address the current status of opioid treatment and OUD for CNCP in S Korea a country with moderate opioid consumption since 2010 The availability of up-to-date data on OUD is necessary for the development of national guidelines to prevent severe harms of opioids enhance patients and physicians satisfaction potentiate opioids benefits and guaranty adequate pain control in the CNCP population The ultimate aims of this study are to estimate the frequency of OUD such as OrCC to evaluate the patients functional and psychiatric characteristics and to determine the risk factors associated with OUD in CNCP patients receiving LtOT The results of this study will help to seize the occurrence of OUD in countries with low-moderate opioid consumption thus it will approach the real risk effect of LtOT in CNCP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None